Good afternoon, everyone. I'm Ami Fadia, biotech analyst here at Needham. Welcome to the next session with AtaiBeckley. It's my pleasure to be hosting Srini Rao, who's the co-founder and CEO of the company. Srini, thanks for taking the time to participate in this event. I appreciate your time. Maybe if we could get started with a quick overview of the company and the priorities for the company for this year, and then we'll dive into Q&A. All right. Sounds good, Ami. Well, thank you very much for having me. Really do appreciate your time. Yeah, very quickly, AtaiBeckley is a clinical-stage company. We're actually late-stage clinical at this point, focused on mental health, focused on indications of large unmet medical need, and utilizing as treatments common neuroplastogens, psychedelic-based neuroplastogens that have a short psychedelic duration. We really do believe that's the future of the psychedelic therapy space. Compounds that fit into the existing infrastructure that's already been established for Spravato for treatment-resistant depression. We have three assets in our pipeline, BPL-003, which is an intranasal formulation of 5-MeO-DMT. That's going to be entering phase III very soon for treatment-resistant depression. We have VLS-01, which is an oral transmucosal thin film formulation of DMT that is also currently in treatment-resistant depression, phase II, readout at the end of this year. We have EMP-01, which is an oral formulation of R-MDMA, single enantiomer. We had a positive readout recently in a different indication, social anxiety disorder. The company itself, it was atai for a long time, and it was Beckley separately, and we actually merged in November of last year, thus forming AtaiBeckley. That brought BPL-003 into the portfolio and also redomiciled the company as well from Europe to the United States at the very end of last year. Okay, great. Srini, before we dive into some of your key products, I wanted to maybe just get your thoughts on what's happening in the psychedelic landscape today, and why is now a good time for investors to be thinking about really kind of digging into the space and learning more about it? What's changed in the last couple of years or the recent maybe 24 months? Yeah, there's been quite a bit, actually. This is a space that really kicked off in earnest in kind of the 2018, 2019 kind of timeframe. There were multiple IPOs in 2020. What's really changed is a number of data readouts that have come up along the way, and the last year or two in particular. That did in fact start with, I believe, the BPL-003 readout, which we'll talk about, I suspect, our phase IIb readout. That was in the middle of last year. After that, Compass had two phase III readouts as well. They gave the top-line data for their two phase III trials. This year is going to have a number of additional readouts. The totality of the data set for the second Compass trial. MindMed, which is developing an LSD formulation, will have a total of 3 phase III readouts this year. Compass is anticipated to file their NDA later this year and could have approval. They're doing a rolling submission, so they could have an approval roughly a year from now. Right? I think that's been a really critical bit. We've had these later-stage, large studies that have been reading out that have really kind of brought even skeptics into the fold. This is a revolutionary class of medications for a range of indications in mental health, and the data is really showing that. I think beyond that, there's validation for that concept from two large strategics. There was AbbVie that acquired uncertain, which is an early-stage psychedelic compound, paying a substantial amount of money up front for that. Then more recently, Otsuka acquired a company called Transcend, which is developing a therapy for PTSD. All of this is in this context of very successful sales that Johnson & Johnson is having with Spravato, $2 billion-plus this year. Yeah. Okay, great. Let's talk about BPL-003. Now, fundamentally, how is it different from these different psychedelics that are in development? How is it different from Spravato, which is not exactly- Yeah a psychedelic, and some of these other companies that you mentioned, the Compass, the LSD, and psilocybin? Yeah. It's a good question. I would kind of put Spravato as being kind of psychedelic adjacent, right? Yeah. It's got some of the features. It's interventional psychiatry. In other words, you're going to a doctor's office to get the medication, right? That's what really characterized it. That's what was the unique bit about Spravato. The other bit is that compared to the history of antidepressant therapy, where you take a pill every day, and over time, you get benefit or you don't, you get a lot of side effects, Spravato was relatively almost the next day you're getting benefit, right? That's pretty groundbreaking for the space. Now, the problem with Spravato is that it does not have durability. Most people are getting this drug on a very frequent basis. In fact, in our own research, it's about 70% of folks are getting it on a weekly basis. This means that patients are basically having to make a decision of. You know, feeling better or actually being more involved in their life. Most people can't take a day out every week for therapy. That's been a challenge. That's the promise, and that's what psychedelics can address. They have the rapidity of onset, but they also have the durability of response. That's what's really exciting about this class of compounds. Now, in terms of LSD, psilocybin versus our products, the big differences are duration of action. Both psilocybin and, in particular, LSD, have very long durations of psychedelic effects. In the case of psilocybin, it's on the order of 4-6 hours. Basically, the patient is in the doctor's office the entirety of the day. If there is a blood pressure elevation or some sort of anxiety, you have a little bit of margin at the end of the day to kind of get that patient under control and discharged. In the case of LSD, it's more than the entirety of the day. It can take 8 hours just for the psychedelic effect to sort of wrap up. We are looking at something, and we basically started the company around this, or the start of the development of these programs around this, is to get something that fits completely into the Spravato paradigm. Spravato, you come in, you are dosed, and you have to be monitored for 2 hours. That's what we are targeting. Both BPL and BLS are cleanly fit into that two-hour window. The psychedelic effects, all of the subjective effects, basically wrap up in kind of the 90-minute or less timeframe. Help us sort of also understand the data in terms of the efficacy that you demonstrated in your phase II study. How does it compare to either Spravato or what patients can get by taking a once-a-day pill at home? Yeah. There were a couple of questions that we wanted to resolve with the trial, right? The first thing was answering the question that we've been sort of talking about, which is how does duration of psychedelic effect impact the magnitude of efficacy but also durability, right? That was not really well known prior to that readout of BPL-003 in the middle of last year. Mm-hmm. Compass, they were the leaders in the space, and they are the leaders in terms of being the first drug to market in all likelihood. They had run a clinical study that demonstrated about a 6.6-point delta at the primary endpoint with a single administration of psilocybin. You dose it, and at 3 weeks you got this 6.6-point delta. There was durability out to 12 weeks. The BPL-003 trial was actually structured in a very similar fashion. It's a single administration of BPL-003. There's a very low dose comparator that's sub-perceptual, so it's basically a placebo. And then there was an intermediate dose and a high dose. And what we found is at 4 weeks, so a week later, we had a negative 6.2-point change. And then we looked out to 8 weeks, not 12, but at 8 weeks, there was maintenance of effect. In fact, a very robust, it's over a 5.5-point change even at 8 weeks. That was the result that was exciting. It basically suggested that even with a very short duration, over 80% of patients were ready for discharge actually by 2 hours. That's what was really exciting about this. Beyond that, we had an open-label extension. You actually got continuing benefit. The open-label extension had 1 additional dose. No matter which group they came in from, they got a nice additional benefit. Then in the case of those patients that got a dose in the core study and in the open-label extension, there was a continuing benefit over time. There was some sort of resolution to some of these symptoms. Ultimately, you ended up with 4-5 patients in response, and then two-thirds of the patients in remission by the end of 16 weeks. How does this compare to Spravato? Well, at 4 weeks, the data looks surprisingly similar between Spravato and BPL-003. During that time, folks on Spravato have gotten 8 administrations. They've had to go to the doctor's office 8 times versus 1 administration with BPL-003. That's the value add here. You talked about the added benefit that patients saw on the open label as they got kind of the additional dose. Certainly, it seems that there is a benefit when you have kind of the initial dose and the induction dose. How does all of this sort of translate into durability of effect? Because ultimately, I think what physicians and patients, as we get feedback from experts, are trying to understand is, great, it is fantastic that patients don't have to come back every week like they have to come back with Spravato, but what are we looking at? I think the concept becomes more relevant when you end up having sort of your payer discussions and price of the treatment. Maybe give us some initial thoughts on how do you see that translating to durability. Yeah. Again, the data that we've seen across compounds at this point is that there is robust durability, right? There's some reduction or symptoms slowly decaying over time, right, or increasing over time. For the most part, many patients do in fact stay in remission or response many weeks out, right? I think that's important. Most of the competitors currently are looking at roughly 3-month redosing as needed. You know, that's good. I think that certainly improves quality of life of the patients pretty significantly. In our own program, because the duration of psychedelic effect is so short because actually the FDA was comfortable even in phase III for us, having patients get discharged as soon as 2 hours. We decided that we could actually potentially improve further by allowing either 8- or 12-week dosing. Because the anticipation is some patients will, again, require a redose a little bit sooner. They'll have more of a decay. Things do happen in their life. Something can come up in their life, and that precipitates the symptoms coming back. By all means, we don't want to wait until the patient's in full-blown depression again. This allows us a little bit more flexibility. Maybe talk to us about the two phase III studies that have been initiated. Maybe talk about the trial design, how you ended up picking the 8-milligram dose out of the couple of doses that you had evaluated in phase II. Yeah, it's a good question. It's interesting to note that unlike the first generation compounds, which are psilocybin and LSD, there you had a lot of information coming into the trials, right? Because there's been a lot of history of use of those compounds. Many studies have looked at 25 milligrams of psilocybin, which is the dose that Compass is going forward with. Other, many other studies have looked at a range of doses with LSD, including the 100-microgram dose. In the case of BPL, because of the formulation shift, we really had no idea of what the dose should be. It's more like a traditional drug development program. In the phase I, we basically did a single ascending dose design and found the MTD, essentially, which was 12 milligrams. Then we picked another dose underneath it, which had very similar subjective effects. The phase I looked a little bit better tolerated. The idea was to go into the phase II with those two doses and see if there was a therapeutic index trade-off that was worth exploring. What we found in the phase II, and the numbers I've kind of quoted, were actually for the 8-milligram dose. It turned out that numerically, the 8-milligram dose had somewhat better efficacy than the 12-milligram dose. Of course, the tolerability, while both doses were quite well-tolerated, the 8-milligram dose was better tolerated than the 12. When we look at the data a little bit more closely, there was a bit more anxiety, et cetera, that was associated with the 12-milligram dose. It was probably a little on the high side. What we're doing in the phase III is actually moving forward with the 8-milligram dose. Now, in terms of the two, there are two phase III trials. The first one is single administration, 3 different arms, so true placebo, the 8-milligram dose, as we've talked about, and a 4-milligram intermediate dose, and it's a 2, 1, 2 distribution. Primary endpoint is at 4 weeks. The total duration of blinded trial is 12 weeks. There's an open-label extension that goes beyond that. I kind of touched upon this a little bit. Basically, the patients can get redosed. It's nominally every 12 weeks, but they can get redosed at 8 weeks, if the doctor and the patient deem that that's appropriate. In the case of the second trial, it's 2 arms. Here we're doing something slightly different. We're looking at 2 doses. So it's 2 doses 2 weeks apart. Primary endpoint is at 4 weeks. Both doses are 8, versus placebo. The trial goes out to 12 weeks, just like the first one, and the open-label extension is exactly the same. The idea there is to generate data that allows for flexibility. I think that's what we keep coming back to. It's flexibility for the doc and the patient. If they respond well to one dose, by all means, just do one dose. If the doctor and the patient feel that they could benefit from another one, gives them the flexibility. Compass is doing something very similar in their own phase III program. Of course, as I said, 8 or 12 weeks redose just based on symptoms. Even in both of these studies, while the blinded portion is 12 weeks, the patients will have the opportunity at 8 weeks to reevaluate with their physicians and see if they want to take a second dose. Not in the core studies, but in the open-label extension. In the open-label. The core study is 12 weeks, and it's you get one dose, or you get two doses, and that part's fixed. Right. In the open-label extension, again, it's nominally every 12 weeks, but you can redose at 8 weeks if it's appropriate. I didn't mention the size. The first trial is around 350 patients, and the second trial is right around 300 patients. The 4 milligram dose gives you the opportunity to sort of address that functional unblinding aspect. Yeah which has been a focus of discussion with this class of drugs in general. Yeah. Okay. Yeah. That's exactly right. Mm-hmm. Yeah. Okay. Correct. I think this question comes up because there was this article by the FDA stating that there's the possibility of a single trial to support approval. With the data that you have generated with your phase I, phase II studies, do you still believe that you need two studies in order to seek an approval? Yeah, it's a good question. It really comes down more to the safety database. That's what the agency tends to focus on. Mm. Depression is a chronic indication, right? Mm. As we've talked about, there's an open-label extension where you're redosing. In general, when an indication is chronic, there is a requirement to generate a certain number of exposures at different time points, right? Traditionally, for a drug that's taken daily, presumably for the rest of your life. You get 300-600 at six months and 100 at a year. Really the number of exposures is being driven by the recruits filling the top of the funnel, so you can actually meet those criteria around 300 and 100. That's what's really driving it. Yeah, for a chronic indication, that's the important thing. You typically don't like to shove everything into one trial, right? That's a little bit fraught. This also allowed us to generate a lot of really helpful data for both the regulators, and also ultimately for the patients and the doctors. That flexibility notion, I think, is going to be really important. That's the true answer here. Beyond that, it's going to be totality of evidence. The phase II obviously comes into play in that context. We'll have a lot of very rich data set at the end of this program that'll support approval, but also support all the payer discussions and everything else that are equally important once you get to commercial. Maybe just a last question on your phase III trials. You've sort of done a lot of work systematically to identify the right dose, to explore whether sort of a second dose can help propel a patient forward in kind of that improved efficacy. Built in the flexibility with regards to retreatment. The functional unblinding is also sort of sufficiently addressed. What keeps you up at night with sort of the work that has been done and kind of the way the trials have been designed? Honestly, I'm pretty happy with the way things have come together with this program, to be perfectly honest with you. This was the first program that's really looking at short duration. It's something that was, again, really engineered for a particular kind of profile, a particular PK profile, a particular pharmacodynamic profile. It wasn't resting on previous data specifically, right? 5-methoxy in particular did not have much data in terms of antidepressant effect beyond sort of anecdotal data. There were no real double-blind trials. This program has really come together nicely. It was an amazing discussion with the agency that's a very supportive agency. Obviously, that was evidenced by the fact that we got breakthrough designation, even in the context of Spravato being approved for the same indication, right? This is the first drug that got a breakthrough designation after the Spravato approval. Lots of enthusiasm there. I think the phase III program is a robust one. It is also a simple one. I like keeping phase III trial programs simple. Don't try and reinvent a lot of wheels. You got a set of questions you got to answer. Obviously, regulatory questions. You've got a set of commercial questions that you need to address and some of the flexibility that we've talked about. Just you keep it focused and don't try to do too much that's new or innovative. You really just want to get through, and get the core questions answered, and that's, I think, exactly what we're doing with this program. Mm-hmm. Okay. Maybe give us some initial thoughts on the go-to-market strategy. Maybe sort of put in context what is sort of the expected timeline by which you could sort of anticipate an approval come through, and then kind of the market positioning. Yeah. We have guided the top line for both of these trials will be in the first quarter of 2029, at that time or before. Obviously, we'll provide more color as time progresses, right? We're initiating these studies now. We have a lot of experience with TRD studies, right? We have done the phase II, obviously, with BPL, but we've also got a phase IIb currently ongoing with VLS. We know where the hiccups are, and we have a lot of ideas on how to improve timelines. There are some other elements to this that we've had discussions with the agency about that we haven't really disclosed yet, but will over time, that we believe will also facilitate enrollment and thus timelines. That's kind of the big picture in terms of timing. In terms of positioning, this is something that we believe is more or less a drag and drop into a clinic that's currently delivering Spravato, because of the same kind of time requirement and everything else. When we talk to the sites that are currently high volume prescribers for Spravato, they like this ability to turn around a room very quickly. All right. They, in many situations, are dosing 2, 3, sometimes even 4 patients per room in a given day. So that ability to kind of have a profile that's very similar is very appealing to them. So that is our niche, and I think that, again, this short duration is really important. We had an investor day recently, and we had a couple of KOLs on. They kind of brought up some other pragmatic things. The patients that are getting psilocybin, that are getting LSD, come out of it pretty tired, right? It's a long day. It's an emotionally draining day with the psychedelic experience. It's much easier with coming off of BPL because it is so much shorter. We're talking about this 2-hour window. We're talking about 4-6 hours or longer. The really intense psychedelic experience is very short. It's 30-45 minutes, somewhere in that ballpark for BPL versus several hours for psilocybin and more hours for LSD. This really intense period is quite short. The patients are in a better position after that. There's a facilitator in the room. That is an exhausting job, as it turns out, when the patient has a very long experience. It's just, if it's a short experience and the facilitator is. They're really focused on the patient for 45 minutes, and then the patient's kind of coming off or going up or coming down, it's just a much easier task. I think we're going to be very well-positioned to really get to those high-volume Spravato sites. It is interesting. It's such a concentrated market. We recently got numbers for Spravato for Q1. I think it was about 40% or 47% year-on-year increase, I believe, and by quarter. It's well over $2 billion this year. It was $1.7 last year. It's doing very well. Our understanding is that it's a small number. There's like 5,000 sites that have been through the REMS, so it's a small percentage of sites that are actually generating the vast majority of that revenue on the order of 600 sites, maybe 700 sites. Commercially, this is a very tractable problem for a small company, right? Mm-hmm. We're talking about a sales force that isn't that big. 50-100 reps, depending on the geography, obviously, would be well-suited for this. Obviously medical affairs and beyond. I think it's going to be an exciting time, and it's an exciting commercial build as well, and something I'm certainly looking forward to. Yeah. We sometimes get questions, sometimes from investors, but sometimes from some physicians who are sort of highlighting that there might be some uncertainty around what the REMS program could look like. Can you sort of help us understand what about the REMS program is sort of unknown, or are there aspects of it that you're trying to just get clarity on from the FDA around things like, what is the qualification of the person that's going to be needed in the room to monitor? Can there be central monitoring? Because it appears that those things might be part of the calculus from the clinic's perspective around the profitability and sort of the economics for them. Yeah, it's a good question. The agency has had a requirement to have someone in the room. They have softened a little bit over time. When BPL-003 went through pre-IND, there was an absolute requirement to have two people in the room. Once we got VLS-01 through its pre-IND, the agency had said, "Well, if there's AV monitoring, if there's a camera in the room, you can have one person in the room, and then you can have someone else that's outside." I think that overall the requirements should be less for a short-duration psychedelic for some of the reasons that we outlined. The patients tend to be kind of inwardly focused with all these compounds. Pragmatically, there's more requirements because, when you're 4, 6, 8 hours, you have to go to the bathroom and everything else, right? There's just that challenge. Anyway, right now there is this requirement. You do need a bachelor's degree, so it is a level above, say, a medical assistant. We hope to generate the data that over time, we will be able to kind of step back from that. I'm sure the other companies are looking at that as well. Got it. Okay. That's quite helpful to understand. Maybe just sort of a broader market question. We discussed earlier in our conversation that there are multiple companies that are in the fray, and there could be several different products that are out in the market in the next couple of years. There are about 7,000, 8,000 clinics that are utilizing Spravato currently. Do you think that there is capacity either for the number of clinics to expand or the capacity within the clinics to expand? How much of the broad-scale adoption is dependent upon that bottleneck of kind of the capacity in the space? Well, I think it's important to start with the unmet need, right? Depression is a very large indication in the United States. Obviously, it's north of 15 million people are impacted, just depending on how you define it. Treatment-resistant depression, that subset that really are not responding, that have had multiple failures in their past, again, depending on how you define it, is somewhere north of 3 million people. Spravato is generating those very large revenue numbers based on a very small number of patients. The latest number that I saw is actually cumulative, about 200,000-250,000 patients since 2019. That's where you're getting these numbers in terms of unique patients. It's a very small fraction of the total market of TRD. I'd say that's an important place to start. In other words, there's lots of room to expand within that market. It took a while for Johnson & Johnson to really hit their stride with Spravato because there was more complexity around this interventional psychiatry kind of paradigm. Obviously, the commercial might, I should say, of Johnson & Johnson was critical to this. They have figured this out. They have cracked that nut in terms of making sure that the sites get reimbursed, et cetera. I do believe there's going to be room for more clinics. Right now they are not incredibly well geographically distributed. I think it's like 17, 18 states or maybe a little bit more at this point, but it's not many states. There's clearly room for expansion beyond that. It will, of course, come down to making sure that it's worth the doctor's time to do all this, right? Within even the high volume sites, this gets back to what we talked about earlier. They do want to be able to use these patients' rooms more than once per day, have more than one patient in a room per day. That has come up. Even despite that, it depends on the clinic. We're talking somewhere between 30%-80% utilization. There's certainly some unused capacity at this point. Important to note also that if you think about Spravato, you can't live that far away from a physician's office, right? You just can't. Because unless you're pulling someone else out of work every day to drive you back and forth, or you're paying $200 in Uber fees, it's just challenging, right? The other nice thing is, with infrequent dosing, your geographic catchment area is a lot larger. I think that that's also going to help kind of expand this market. Yeah, that makes sense. Okay. Any last comments on kind of the size of the TRD market opportunity across psychedelic? Yeah. As I said, unfortunately, it's a very large unmet medical need. We've been focusing on treatment-resistant depression and depression writ large. Lots of patients and lots of folks that are really struggling. SSRIs have been around forever, SNRIs and all the augments have been around forever. Many people just aren't getting the benefit that they need there. Many people just can't deal with the dosing frequency of Spravato. There's just lots of opportunity here to fill out that gap from about 2%-10% of that total addressable market. Yeah. Okay. That makes sense. I want to switch gears to VLS-01. It is also a DMT, and you're also evaluating in TRD, but the mode of administration is different. Of course, there's data expected later in the year in the second half. What should we be looking for? Should we look for the data to look similar to what maybe BPL-003 looked like? Kind of some early thoughts on how this fits in with BPL-003. Yeah. As I mentioned at the outset, AtaiBeckley came together as a result of the merger with atai and Beckley, right? atai, we were developing, at that time, VLS, and Beckley was developing BPL. That's why they were kind of parallel tracking in TRD. Again, we are essentially the only game in town in terms of late-stage, short-duration therapies, and that's why it made a lot of sense to come together. That's why the VLS is in TRD. Expectations are. I wouldn't say that all of these trials have had sort of similar changes and benefits in the kind of 3, 4, 6-week primary endpoint kind of timeframe in terms of numbers. I would certainly expect something very similar there. One point of differentiation with that trial is that it's a 2-dose induction paradigm. A little bit more de-risked than 5-MeO-DMT was prior to the BPL trial. There's been a couple studies that have been done with DMT in different formats showing good benefit. Very different compounds subjectively, at least in the phase I ones. The two compounds look very different. If you look at anecdotal use, if you look at recreational use, people do describe 5-MeO-DMT as being very different subjectively than DMT. Pharmacologically very different. It kind of makes sense. I think they'll find their individual niches within the space. BPL is locked and loaded for treatment-resistant depression. We have more latitude with VLS-01 within the depression spectrum. There's MDD itself, but there's also MDD with different associated symptoms, as an example. That's certainly something that we're looking at. There are other indications that are just beyond that, including some of the other anxiety indications like GAD. We are exploring a number of different things, and of course, a lot of this will come down to what we see in that study. Remind me, what are the endpoints in that study? Is it just MADRS or are there other sort of anxiety-related symptoms in there as well? Yeah. Obviously, it's the MADRS at 4 weeks, and we do go out to 12 weeks after the second dose, a total of 14 weeks. We have very good durability data coming out of that trial. We have the GAD-7 and a few other things as well as quality-of-life type of parameters as well. There's a few things that we'll get a sense of the impact on anxiety, for sure. Mm-hmm. Okay. In the few minutes that we have left, I do want to touch upon EMP-01, for which you disclosed data recently in social anxiety disorder. Maybe if you could sort of lay out your view of what that data demonstrated and what are the next steps. Yeah. Just giving a little bit of a quick history on that. This is R-MDMA, so single enantiomer. We ran a phase I trial with that. The idea was that R-MDMA seems to have more of the serotonergic activity. S-MDMA certainly has more stimulant-type activity. We anticipated getting a better therapeutic index with our MDMA. Well, in the phase I, we were obviously able to push the dose a lot higher, and it turned out to have a very different and unique profile. You ended up with something that had a lot of empathogenic and entactogenic properties like MDMA, but also psychedelic effects. They were somewhat subtly different psychedelic effects. This is our third program, right? It's the third asset. We were very comfortable in doing something different. You could have done MDD, TRD, you could have done GAD. SAD is a huge indication, and it's different than those two. GAD and MDD are related. It's basically kind of a spectrum. You're ruminating. One, you're looking backwards, the other one, you're looking forward. You're depressed or you're anxious in a sense. That's kind of how that breaks out. Social anxiety disorder, obviously has gotten a lot of press, did get a lot of press during COVID. People didn't talk about it as much. It's kind of like where depression or TRD was maybe a decade ago, right? That's what really kind of intrigued us by this indication. No one had really done any work in it. We had a new drug and with a differentiated profile, and we wanted to go after a new indication and learn a lot about both. That's what we did. It was a double-blind, placebo-controlled trial, 70 patients in total, 35/35, essentially. 2 administrations of the MP-01 in day 1, and then 4 weeks later, a primary endpoint at 6 weeks. The endpoint was something called the LSAS, the Liebowitz Social Anxiety Scale. This endpoint was the basis of approval a long time ago with some SSRIs and an SNRI. Interestingly enough, when you think about depression, you're looking at mood, and that can change pretty quickly. That's why you get MADRS changes the next morning, right? Your mood can change during the day, right? Depending on what's going on during the course of the day. The LSAS actually is physician-administered, and it's looking at behavior. Behavior does not change on a day-to-day basis, typically, right? In particular, you're trying to change behaviors like how likely are you going to go to a party or something like that, or how likely are you going to just speak on the phone or speak to a stranger? These are sort of questions that are asked in the LSAS. Until you've been put in that situation, you don't really know. You can't ask that question the morning after the drug and say, "Hmm, how do I answer that question? Because I don't know. I have not been in any situation where that's salient." It is a slower change. The change we saw at six weeks at a moderate effect size was 0.45. Similar, it was about 0.85 change from baseline, placebo subtracted, which was comparable to the SSRIs, but the SSRIs were that was at 12 weeks. There was a lot of enthusiasm for this data. The KOLs are quite enthusiastic. A lot of people with SAD don't take the SSRIs. They give you lots of side effects, and people tend to brush that off. There was also a lot of discussion about the fact that the trial was just short. If we had let it run because it's a behavioral change endpoint, you would have seen more of a separation over time. Obviously, we don't have data for that, but just because of the nature of the endpoint, we'd anticipate it, and that's what the KOLs were really excited about. In terms of next steps, we've got some additional data coming. We've talked about the LSAS. It's physician-administered. There's also the patient-administered side of things. There's behavioral change measures that, how is the patient feeling about these different scenarios? Again, it can't happen immediately, but it can happen more rapidly than a physician-assessed kind of score. That's something that we're waiting for. We'll have those data relatively soon, and then we're going to provide guidance on how we want to progress the asset. It looks like we're out of time, I will have to close here. Srini, thank you so much for your time today, and I appreciate you participating in our conference. Absolutely. Thank you, Ami